The invention deals with a medical marking device which is useful for making lines and marks on soft and hard tissue in preparation for surgery or other medical applications in which medical personnel are required to draw lines of different widths or colors or, to make reference points on the surface or under the surface of the skin or other appropriate hard and soft tissues of a body.
It is known to those skilled in the art that a number of medical procedures require the placement of various types of lines and dot-type markings on the surface of tissue or, the placement of reference points just under the surface of the tissue.
Furthermore, it is known to those skilled in the art that surgeons need to draw lines on the surfaces of hard and soft tissue of the body before surgery, to mark the position of the incision line. A surgeon needs to make these markings on tissue such that the lines can be easily drawn with desirable and consistent line widths. Also, the markings sometimes need to vary in color. These lines and marks need to be drawn with precision, and in the case of the dots, the surgeon may use the dots to do a surgical outline, but then must be able to connect the dots, and thus, the surgeon must be able to see the dots and draw the connecting line with precision. Such demands are even greater when small children are subjected to corrective surgery. The younger the child, the more precise the surgical treatment has to be in order for a scar from such surgery to be less visible after the healing process.
Serious obstacles have been created, particularly for reconstructive surgeons by the unavailability of a device which a surgeon can use to precisely and preferably "on demand" place reference points just under the surface of the skin or other body tissues. When placed just under the surface of tissues, these reference marks remain visible only temporarily in such tissues. In addition, the device must be capable of being sterilized before use.
The reference points are placed by the surgeon prior to surgical procedures. Once the surgical procedure has started, body fluids may smear the original lines when the fluids are being wiped off the body, and the original lines may become completely erased. As indicated supra, precise redrawing of original lines is possible only if a surgeon can place these multiple reference points into the tissue along the path of the line and redraw lines between these reference points. Placement of the reference points is a tedious and hard task. The precision and ease by which surgeons can place these reference points to a large extent determines how precisely the surgeon can carry out complicated reconstructive and corrective surgery. The more precise a surgeon can carry out the surgical procedure, the more likely after the healing process the patient will have minimized visibility of the surgical scar and the more likely the body tissue will be reconstructed in a proper manner.
Some of today's surgeons do not make reference points at all since there is no really good commercially available device to make such points.
Currently available, and mostly used surgical marking devices for drawing lines on the surface of a tissue are felt-tipped or fiber-tipped. These devices are identical in construction to ordinary writing felt tip or fiber tip pens. In surgical applications, such pens are sterilized and filled with appropriate FDA approved ink or coloring agents. These commercially available pens draw lines reasonably well on dry skin, however, when the skin is wet, such as by fluids, such as, for example, saline, blood, and the like, they absorb these fluids and cease leaving lines and/or marks. Consequently, surgeons have to use more than one of these pens during a single surgery, especially if they have to re-draw the lines. Currently, commercially available pens are not only cost ineffective choices, with no alternatives, but more importantly, the unreliable and unpredictable performance of these pens frustrates most of the surgeons, especially those doing intricate surgical procedures.
Some surgeons refuse to use existing commercially available pens and they use their own home made devices which are not only inconvenient to use, but may endanger the patient, because such devices cannot always be adequately sterilized. Another disadvantage of using currently commercially available surgical grade felt and fiber tip based pens is the difficulty in controlling line width. The width of lines is often unpredictable depending on the angle under which the pen is used for drawing, on the softness of felt used in the felt tip pens, and the pressure that the surgeon exerts on the pen while drawing on the surface of the tissue. The line width becomes, to a large extent, an arbitrary and difficult to control process, since the width can change during the drawing of a single line. Line width cannot be precisely predetermined. This is particularly the case when a surgeon writes on the surface of a wet body tissue. Marks are typically wider than the intended incision, for example in the repair of a cleft lip, complicating the surgical procedure and restricting precision of the corrective surgery.
The "home made" procedure identified above can be found essentially in U.S. Pat. No. 4,508,106, which issued Apr. 2, 1985 to Angres, in which the eye lid is anesthetized and stabilized, and a series of needles coated with pigment solution is inserted into the edge of the eye lid to implant the pigment solution into the dermal and/or epidermal layer of skin beneath the eye lid edge.
There is disclosed in U.S. Pat. No. 4,665,912, which issued May 19, 1987 to Burton, a device which operates in a similar manner to a ball point pen configuration, but with the modification that the tubular barrel has a narrow opening at one end, and there is a needle carried in the barrel which can extend out of the barrel. The needle and opening form an annular flow passage for a dye carried in a reservoir. The device can move the needle in and out of the opening by an internal device which extends and retracts the needle and in the process, provides the dye onto, or into the skin. It should be noted that the internal device is spring loaded to manually move a tapered needle. It requires the dye to have a viscosity substantially higher than water. Pens used for tattooing require that the dye have a viscosity substantially greater than that of water. In the instant invention, the preferred viscosity of the dye/ink is actually the viscosity of water, even though the viscosity of the dye/ink can be higher or lower than that of water. Thus, this device is substantially different from the devices of the present invention.
U.S. Pat. No. 4,671,277, which issued on Jun. 9, 1987 to Beuchat deals with a device for controlling the dispensing of pigments in solution by the use of a reciprocating needle. This device is driven by a motor and is the typical "tattoo" pen.
Yet another tattoo device can be found in U.S. Pat. No. 4,719,825, which issued on Jan. 19, 1988 in which the tattooing device includes a disposable syringe in which a tattoo dye is dispensed through a passageway in a needle of the syringe. A cam member is rotated to rotate a clutch rod held in a clutch member. The clutch rod rotates a threaded rod through a fixed nut member that causes the threaded rod to move linearly towards the syringe to displace a plunger pin fixed to the threaded rod. The plunger pin thereby displaces a plunger of the syringe to dispense the tattoo dye through the needle.
A surgical marking pen is disclosed in U.S. Pat. No. 5,496,304, which issued on Mar. 5, 1996 to Chasan, in which there is disclosed an apparatus for penetrating the epidermis. It provides for the delivery of a marking agent from a reservoir to the skin by pressure on the reservoir.
Finally, there is disclosed in U.S. Pat. No. 5,810,862, an instrument for the intradermal injection of pigments, which patent issued on Sep. 22, 1998 to Pilmanis, in which a there is an elongated tubular barrel member and a tubular grip member which is mounted at the forward end of the barrel member in coaxial relationship. The needle assembly is inserted into the barrel member in a manner such that the free ends of the individual needles project through the forward end of the grip member. A resilient member is provided within the tubular member for biasing the needle assembly toward the forward end of the grip member so that the free ends of the needles will project out through the forward end of the grip member.
Although the U.S. patent literature discloses surgical marking tools, there appears to be commercially available, only felt tipped and fiber tipped based pens for surgical use. The U.S. patent literature discussed above discloses other marking approaches, such as ball point pens, roller point pens, multiple needles, and the like. These technologies suffer from a lack of ability to draw narrow lines and lack the ability to provide preciseness and cannot generally be used to make a reference point under the surface of a tissue that will remain visible.
None of the devices of the prior art show or describe the devices of the instant invention, and none of the devices of the prior art have the advantages of the devices of the instant invention, which will be described infra.